ES2931824T3 - Devices for moistening catheters - Google Patents

Abstract

A urinary catheter wetting apparatus (121) has a chamber defined by a front section (123) opposite a rear section (125), each of which has an opening (143, 153) of which are axially aligned. A catheter tube is connected to a connector (161), the latter of which extends through the chamber and initially seals the two openings. The connector can slide through the first facial surface (129) of the front section and the second end wall (131) of the rear section so that the catheter tube can pass through the chamber. A wetting applicator (151) containing a wetting agent is disposed in the chamber. Upon use, the connector passes through the chamber, applying pressure to the wetting applicator, thereby releasing the wetting agent from the wetting applicator and onto the catheter tubing as it follows the connector through the chamber. (Automatic translation with Google Translate, without legal value)

Description

DESCRIPTION

Devices for moistening catheters

BACKGROUND OF DISCLOSURE

Disclosure field

The present disclosure relates to devices for applying a fluid to an outer surface of a medical tube, including a medical tube that has a hollow lumen. The present description refers to said wetting devices for medical tubes in urinary catheters and their packaging or wrappers.

Description of Related Art

A catheter is a tubular medical device designed to be inserted into channels, vessels, passages, or body cavities to allow injection, drainage, or withdrawal of fluids or substances, or to maintain the opening of a passage. Catheters can be used to transfer fluids and fluidized substances. For example, a catheter can be used as a drainage tube to be inserted into the bladder through the urethra to drain the bladder.

A urinary catheter is usually left in place permanently for a specific period of time. An intermittent urinary catheter is usually removed after a single use, for example, when the bladder is emptied.

In women, a urinary catheter tube is normally inserted into the urinary tract through the urethral meatus. In men, a urinary catheter tube is usually inserted into the urinary tract through the penis.

When inserting a urinary catheter, lubrication can minimize friction, risk of infection, and trauma to the urethra. Some urinary catheters are pre-lubricated and self-contained. A disadvantage of such a self-contained pre-lubricated catheter is that the lubricant can be dispersed throughout the catheter package so that components other than the catheter tubing, such as the manipulation sleeve and funnel, can become lubricated. . This unwanted lubrication can make manipulation of the catheter difficult, advancing the catheter and/or wasting lubricant. In addition, it can make it difficult to hold the catheter, manipulate the cuff or other components, and guide the catheter at the same time, especially when a patient attempts to self-catheterize. In addition, an excessive amount of lubricant can result in significant mess and inconvenience to the user, since it is easy for such amounts to spill from a rigid or flexible container or wrapper. Furthermore, the lubricant may not be retained in the wrapper area but may migrate into the urine collection chamber or bag, causing the chamber or bag walls to collapse and/or stick together, thus making evacuation difficult. .

Urinary catheters and examples of wrappers are described in US9697629, EP2450076 and FR2794638.

DISCLOSURE SUMMARY

In one embodiment of the invention, a wetting device for a tube is defined, comprising: an enclosure enclosing a chamber having at least two openings through which the tube can pass; a moisturizing applicator located in the chamber that has an opening through which the tube can be passed through; wherein the moisturizer applicator is configured to release a wetting agent upon applying pressure from within the chamber to the moisturizer applicator. The tube is a medical catheter tube. In some cases, the catheter is a urinary catheter. In some cases, the urinary catheter is suitable for insertion into the male urethra. In some cases, the urinary catheter is suitable for insertion into the female urethra. In some cases, the moisturizer applicator is squeezable. In some cases, the moisturizer applicator moisturizer is infused with the wetting agent. In some cases, the moisturizer applicator comprises the wetting agent. In the present invention, the enclosure comprises a port for adding the wetting agent to the wetting applicator. Without being part of the present invention, the medical tubing may comprise or may be integrated with a polymer, such as a hydrophilic polymer. Without being part of the present invention, the medical tubing may be coated with a polymer, such as a hydrophilic polymer. Without being part of the present invention, the medical tubing may comprise or may be integrated with a polymer blend of a thermoplastic or thermosetting polymer base material and an amphiphilic block copolymer, for example, as described in Section WO 2011/051439 filed October 29, 2010. Without being part of the present invention, medical tubing may be coated with the polymer blend of a thermoplastic or thermosetting polymer base material and an amphiphilic block copolymer, e.g. example, as described in WO 2011/051439. The present invention further defines a system comprising a wetting device of the present invention and a catheter tube. The system of the present invention further comprises a connector that connects the catheter tube to a funnel. In some cases, the connector is placed inside the wetting device. In some cases, the connector has a first coupler or connection at a first end and a second coupler at a second end, wherein the first coupler and second coupler seal the wetting device until the connector passes through the connector. wetting device. In some cases, at least one region of the connector comprises a diameter greater than the diameter of the opening of the moisturizer applicator. In some cases, the connector applies pressure to the wetting applicator to release the wetting agent as the catheter tube is moved through the wetting device. In some cases, the catheter tube has a non-hydrophilic surface. In some cases, the system comprises a manipulation sleeve, wherein the manipulation sleeve extends over the catheter tube as the catheter tube is withdrawn from the enclosure. In some cases, the system comprises a wetting agent where the wetting agent lubricates the catheter tube.

The invention further defines a method of using a system described herein, comprising removing a catheter tube from a wrapper and wetting the catheter tube, wherein removal and wetting occur substantially simultaneously. The method of using the system of the present invention can substantially simultaneously extend the manipulating sleeve of the system over the catheter tubing as the wetting agent is delivered to the catheter tubing. Without being part of the present invention, a method of use may comprise adding a wetting agent to the wetting device through a port in the enclosure of the wetting device. The method of use of the present invention may not require the addition of a wetting agent to the wetting device. Without being part of the present invention, the method of use may comprise opening a wrapper and drawing a catheter tube out of the wrapper through its funnel, thereby wetting the catheter tube. Without being part of the present invention, one method of treatment comprises inserting the catheter tube into the urethra immediately after removing the catheter tube from the packaging.

The foregoing and other objects, features and advantages of the present description will be apparent and understood by those skilled in the art from the following detailed description and drawings. The invention is defined by the claims.

The patent file or application contains at least one drawing executed in color. The office will provide copies of this patent publication or patent application with drawings in color upon request and payment of the necessary fee.

Figure 1 shows an example of an exploded perspective view of the catheter package showing a wetting device.

Figure 2A shows an example of a perspective view of the catheter wrap of Figure 1 exposed at initiation of use and partial removal of the catheter.

Figure 2B shows an example of a perspective view of the catheter wrap of Figures 1 and 2A after removal of the catheter, showing the exposed cartridge (left side) with the wetting device remaining in the cartridge.

The catheter 110 is partially covered with the protective sleeve 176 and the handle 178.

Figure 3 shows an example of a perspective view of a wetting device with a catheter tube therethrough.

Figure 4 shows an example of a cross section of Figure 3 taken along A-A.

Figure 5 shows an example of an exploded perspective view of the wetting device of Figure 3.

Figure 6 shows an example of a perspective view of the wetting device of Figure 3.

Figure 7 shows an example of an end end view of the wetting device of Figure 3. Figure 8 shows an example of a cross section of the wetting device taken along B-B of Figure 7.

Figure 9 shows an example of a cross section of the wetting device taken along C-C of Figure 8.

Figure 10 shows an example of a cross section of a catheter assembly including a wetting device.

Figure 11 shows an exemplary exterior view of a catheter assembly including a wetting device.

Figure 12 shows an exemplary cross section of a catheter assembly including a wetting device.

Figure 13 shows an exemplary exploded perspective view of the wetting device of Figure 10.

Figure 14 shows an exemplary perspective view (not exploded) of the wetting device of Figure 10.

Figure 15 shows an exemplary side view of the wetting device shown in Figure 14.

Figure 16 shows an exemplary end end view of the wetting device shown in Figure 14.

Figure 17 shows an exemplary cross-sectional view of a catheter assembly with a wetting device.

Figure 18 shows an exemplary cross-sectional view of a catheter assembly with a wetting device.

Figure 19 shows an exemplary perspective view of a wetting device.

Figure 20 shows an exemplary cross-sectional view along E-E of Figure 19. Figure 21 shows an example of a perspective view of a moisturizing applicator of a moisturizing device.

Figure 22 shows an example of a perspective view of a connector of a wetting device. Figure 23 shows an exemplary perspective view of a catheter wrap having a wetting device according to the present disclosure in a packaged state.

Fig. 24 shows an example of a cross-sectional view of Fig. 23 taken along the line F-F showing the wetting device.

Figure 25 shows an example of a view of the package of Figure 23 shown with the actuated catheter in a ready-to-use or wet state.

Figure 26 shows an example of an exemplary partial cross-sectional view of an exemplary wetting device in accordance with the present disclosure.

Figure 27 shows an example of an external view of an exemplary female catheter assembly that may contain a wetting device described herein.

Figure 28 shows a cross-sectional side view of a distal end of an example of a catheter assembly described herein with a wetting device.

Figure 29 shows a top view of an example of an exemplary catheter assembly having a wetting device for use with a female urethra.

This is a view before the extension of the catheter tube and the wetting of the catheter tube.

Figure 30 shows an exploded perspective view of an example of a wetting device. Figure 31 shows a cross section of a side view of an example of a wetting device.

Figure 32 shows a cross section of a side view of a catheter assembly comprising a wetting device.

Figure 33 shows a female catheter assembly with wetting device both in a stored state (prior to use) and a catheter in use (wetting chamber activated).

The accompanying drawings illustrate presently preferred examples of the present disclosure as they relate to urinary catheters, and together with the general description given above and the detailed description given below, explain the principles of the present disclosure. Reference to these examples of disclosed wetting devices specifically described with a urinary catheter is not intended to limit the principles and application of the disclosed wetting device which are equally applicable to other suitable medical articles such as, including but not limited to a feeding tube, tracheal tube, insemination device, balloon catheter, guidewire, and stent. Reference to fluid, liquid, lubricant, or other material disposed in the moisturizing device is not intended to limit the principles and application of the described moisturizing devices, and such material may be equally applicable to specific embodiments, other suitable medical articles, and modifications thereof.

As shown throughout the drawings, the same reference numerals designate the same or corresponding parts.

DETAILED DISCLOSURE DESCRIPTION

The present disclosure provides wetting devices for wetting medical tubing. In some cases, moisturizing comprises lubricating. In some cases, without being part of the present invention, wetting occurs at or shortly before the time of use. In the present invention, wetting occurs simultaneously with removal of the catheter tube from a wrapper.

The present disclosure provides wetting devices that are used to wet catheters. In some cases, the wetting devices described herein are used for indwelling catheters. In some cases, the wetting devices described in this document are used for intermittent catheters. By way of non-limiting example, the wetting devices described herein can be used with urinary catheters. In some cases, the urinary catheter is a male urinary catheter (eg, suitable for use with a male urethra). In some cases, the urinary catheter is a female urinary catheter (eg, suitable for use with a female urethra). Additionally, by way of non-limiting example, the wetting devices described herein can be used to moisten feeding tubes prior to their insertion into the esophagus. The wetting devices described herein can also be used to wet a tracheal tube prior to insertion into the trachea. The wetting devices described herein are not limited in use and are intended to be used to insert devices, such as catheters, into various passageways and body cavities. Body passages and cavities include, but are not limited to, the urethra, trachea, esophagus, ear canal, sinus cavity, blood vessel, vagina, and rectum.

As discussed in more detail herein, the present invention provides a wetting device comprising a chamber defined by an enclosure having at least two openings; and a moisturizer applicator having an opening, the moisturizer applicator arranged in the chamber with the opening between the two openings so that when a catheter tube passes through the chamber from one body surface to the other body surface, one surface The outside of the catheter tube is properly moistened by the moisturizing applicator. The wetting device has a body having a plurality of walls including a first end wall opposite a second end wall. In some cases, the at least two openings are axially aligned. In some cases, the moisturizer applicator is compressible and impregnable with the wetting agent. In the present invention, the moisturizer applicator may be loaded with added wetting agent through a port provided through the enclosure thereof for loading wetting agent into the chamber.

The volumes and dimensions of the chambers described in this document depend on a number of factors including, but not limited to, the type of pipe lining, the amount of liquid required to hydrate the lining, the diameter of the pipe, the density of the foam , the absorbency of the foam and the length of the tube that requires hydration. However, the volumes and dimensions must be sized appropriately for a convenient and discreet catheter device. In some cases, the volume of the chamber is between approximately 1 cc3 and 15 cc3. In some cases, the volume of the chamber is between approximately 1 cc3 and 10 cc3. In some cases, the volume of the chamber is between approximately 1 cc3 and 5 cc3. In some cases, the volume of the chamber is between about 3 cc3 and 10 cc3 In some cases, the volume of the chamber is between about 4 cc3 and 10 cc3. In some cases, the volume of the chamber is between about 5 cc3 and 10 cc3. In some cases, the volume of the chamber is between approximately 1 cc3 and 15 cc3.

The present invention further provides a system comprising the wetting device of the invention and a catheter tube. Catheter tubes generally have an insertion end and a drainage end. The catheter tube of the present invention may be initially positioned outside of the chamber of the wetting device. The system of the present invention comprises a connector having an axial through hole in communication with the drainage end of the catheter tube. The connector may span the chamber from the first end wall to the second end wall to seal the two openings so that the chamber is sealed in its pre-use condition. The connector is slidable with respect to the chamber when the catheter is in use so that the insertion end of the catheter tube passes through the openings in the first end wall and the second end wall of the chamber. In some cases, the connector is a cylindrical element having, in order, a first section, a second section, and a third section. The first section and the third section may have a larger inside diameter than the inside diameter of the second section. In some cases, the first section seals one of the two openings and the third section seals the second of the two openings. In the present invention, the catheter tube is connected to a funnel. In some cases, the funnel is disposed on a side of the chamber opposite the catheter tube and in communication with the connector. In some cases, the two openings open when the funnel is pulled through the chamber. In some cases, the system comprises a wrapper. In some cases, the wetting device is integrated into the packaging. In some cases, the tube of the The catheter is encased in an encasement configuration selected from the group consisting of straight, coiled, and curved, and a combination thereof.

The invention further defines a method of using the moisturizing device of the present invention. The method comprises pulling or pushing a catheter tube through the wetting device of the present invention such that an outer surface of the catheter tube is lubricated with the wetting applicator as the catheter passes through the chamber from the first wall of the catheter. end to the second end wall. In some cases, the moisturizer applicator is placed in the chamber with the opening aligned with the two openings, prior to use. The method of the present invention comprises providing a sealed chamber having two aligned openings disposed at opposite ends of the chamber with a connector passing through the chamber with the connector fluidly connecting a catheter to a funnel, the catheter and funnel disposed outside of the camera; pass the catheter through the chamber; thus applying a wetting agent to a surface of the catheter when it is in the chamber. In some cases, the method comprises removing excess lubricant from the catheter surface prior to exiting the chamber. In some cases, the methods described in this document comprise applying a wetting agent to the wetting device. In some cases, the methods described herein comprise applying a moisturizing agent to a moisturizing applicator of the moisturizing device. In some cases, the methods described in this document comprise charging a chamber of the wetting device with a wetting agent through a port in the enclosure of the wetting device.

The wetting devices of the present invention simultaneously wet a catheter tube during removal of the catheter from a wrap. In some cases, the packaging is a case.

Without being part of the present invention, the moisturizing device may be attached to the wrap. As mentioned above, the wetting device of the present invention is configured to be activated to wet a catheter tube when the catheter tube is removed from a wrapper, resulting in the catheter tube being simultaneously wetted during delivery. removal of the catheter from the wrapper. The activating configured wetting device comprises a material that releases a wetting agent when the wetting device is squeezed or compressed. Without being part of the present invention, the wetting device configured to be activated may comprise a wetting agent that is retained by a closure or seal, whereby the seal is broken by applying pressure to the wetting device, thus releasing the wetting agent to enter contact with the catheter tube. Wetting the catheter during wrap removal may allow the catheter tube to be inserted into the urethra in a smooth motion with minimal friction.

The humidification device of the present invention is delimited by an enclosure (eg, a case, frame, or container), wherein the enclosure encloses a chamber. The chamber contains other components of the wetting device, such as the wetting agent. The enclosure can be rigid. The enclosure may be made of a hard plastic. The enclosure may be rigid enough to prevent external pressure on the contents of the enclosure. The enclosure may be made of a material that is semi-rigid and flexible (eg, polymer, rubber, plastic), but rigid enough to prevent external pressure on the contents of the enclosure. The enclosure may be leak resistant. The enclosure can be leak proof. The enclosure can be leak proof when in use. The enclosure can be leak proof when in use. The enclosure may be leak resistant prior to use. The enclosure may be leak-proofed prior to use. The enclosure can be leak resistant after use. The enclosure can be leak-proofed after use. In some cases the enclosure has a rectangular shape, see for example Figures 5 and 6. In some cases the enclosure has a cylindrical shape, see for example Figure 13. It should be appreciated that any shape or combination of shapes can be suitable for use with the present wetting device as long as the same principles and effects are maintained as more particularly described throughout the document.

The front and rear sections, as described herein, may be made of a material that has a low moisture vapor transmission rate (MVTR) (also known as of water or WVTR of English "water vapor transmission rate") , which is a measure of the passage of water vapor through a substance. Low MVTR is desired so that moisture/lube is retained on or in the moisturizer applicator. Having a low and controlled MVTR is helpful in achieving the required quality, safety, and shelf life. In some cases, the front and rear sections are made of polypropylene (PP) or polyethylene terephthalate (PET), or other suitable material with a similar low MVTR. Plastics with a moisture barrier coating, such as a SiOx layer, would also be effective in reducing MVTR to desired levels. In some cases, the material has an MVTR below 1.5 (g*mm)/(m2*24h). In some cases, the material has an MVTR below 1.0 (g*mm)/(m2*24h).

In some cases, the wetting device has at least two wetting device openings through which the catheter tube passes. In some cases, the wetting device is bounded by an enclosure, in which there are at least two openings for the wetting devices in a surface of the enclosure. The wetting device comprises two openings for wetting devices. Without being part of the present invention, the diameter of the catheter tube is the same as at least one opening of the wetting device. Without being part of the present invention, at least one opening of the wetting device is circular. Without being part of the present invention, at least one opening of the wetting device is oval. Without being part of the present invention, at least one opening of the wetting device is polygonal. without being part of the present invention, at least one opening of the wetting device comprises a slot in the enclosure. Without being part of the present invention, at least one opening of the wetting device comprises a plurality of slots in the enclosure, forming a cross, asterisk or star shaped opening. Regardless of the shape of the opening, the openings in the wetting device described herein are generally configured to be tight enough around a catheter tube so that any wetting agent within the enclosure (for example, in the chamber) of the catheter The wetting device cannot pass through the opening of the wetting device unless it is in the catheter tube. In addition, the openings in the wetting device described herein can be tight enough around the catheter tube to remove excess wetting agent from the surface of the catheter tube as the catheter tube exits the chamber.

Without being part of the present invention, the two openings have different diameters. Without being part of the present invention, each of the two openings springs against the connector to create seals. Without being part of the present invention, at least one of the two openings is tapered such that the inside diameter of an opening decreases in the direction away from the chamber.

Without being part of the present invention, a portion of an enclosure of the wetting device described herein defines the perimeter of the opening of the wetting device. The part of the enclosure may be of the same material as the rest of the enclosure. The enclosure portion may comprise a different material than the remaining enclosure. Without being part of the present invention, the perimeter of the opening of the dampening device comprises a more rigid material than the rest of the enclosure. Without being part of the present invention, the perimeter of the opening of the wetting device comprises a material that is softer and more flexible than that of the rest of the enclosure. Without being part of the present invention, the material comprises a foam. Without being part of the present invention, the material comprises a rubber. Without being part of the present invention, the material comprises a polymer. In some cases, the material comprises a plastic.

Without being part of the present invention, the at least one opening of the wetting device is circular and the catheter tube is cylindrical. Without being part of the present invention, the diameter of the catheter tube is less than the diameter of the at least one opening of the wetting device. Without being part of the present invention, the diameter of the catheter tube is only sufficiently smaller than the diameter of the at least two openings in the wetting device to allow the catheter tube to pass through the at least one opening in the device. of moisturizing Without being part of the present invention, the diameter of the catheter tube is about 0.001% to about 1% smaller than the diameter of at least one opening. In some cases, the diameter of the catheter tube is from about 0.01% to about 1% smaller than the diameter of at least one opening. Without being part of the present invention, the diameter of the catheter tube is from about 0.1% to about 1% smaller than the diameter of at least one opening. In some cases, the diameter of the catheter tube is about 0.001% to about 0.01% smaller than the diameter of at least one opening. Without being part of the present invention, the diameter of the catheter tube is from about 0.01% to about 0.1% smaller than the diameter of at least one opening.

Without being part of the present invention, the moisturizing devices described herein comprise a moisturizer applicator. Without being part of the present invention, the moisturizing devices described herein comprise a moisturizer applicator within a chamber of the moisturizing device. In some cases, the wetting applicators described herein apply a wetting agent to the catheter tube. Without being part of the present invention, the wetting applicators described herein are capable of delivering a wetting agent onto a catheter tube. Without being part of the present invention, the wetting applicators described herein are capable of delivering a wetting agent onto a catheter tube. Without being part of the present invention, the chamber is configured to allow a catheter tube to be passed through it, transferring wetting agent or other suitable material from the moisturizing applicator to the catheter tube, forming part of the invention, the catheter tube contacts the moisturizer applicator as it passes through the chamber. Without being part of the present invention, the catheter tube passes through the moisturizer applicator as it passes through the chamber. Without being part of the present invention, the catheter tube applies pressure to the moisturizer applicator as it passes through the chamber, thereby releasing a wetting agent from the moisturizer applicator into the catheter tube. Since the pressure on the wetting applicator is generated by the movement of the catheter tube through the wetting device, it is only necessary to remove the catheter tube from the packaging to obtain the moistened catheter tube. This is advantageous over devices where wetting requires a separate movement or action, such as squeezing a chamber or tube with a wetting agent to distribute the wetting agent over the catheter tube. Having to perform two separate actions can require a kind of coordination that some users have a hard time achieving. Requiring this coordination may also risk dropping or damaging the device, resulting in a contaminated or unusable device. The requirement for this timing can also result in an embarrassing or inconvenient mess caused by spilled wetting agent.

Without being part of the present invention, the wetting applicators described herein are present within the enclosure of the wetting device. Without being part of the present invention, the wetting applicators described herein are present within the enclosure of the wetting device prior to use. use. In some cases, the wetting applicators described herein are present with the wetting agent within the enclosure of the wetting device prior to use. Without being part of the present invention, the moisturizing applicators described herein hold the wetting agent within the enclosure of the moisturizing device prior to use. Without being part of the present invention, the moisturizing applicators described herein are present within the enclosure of the moisturizing device after use. Without being part of the present invention, the moisturizing devices described herein comprise a moisturizing applicator that contains a wetting agent until the catheter tube is removed from its packaging or put into use. Without being part of the present invention, the moisturizer applicator containing a moisturizing agent until use is in an enclosure that is sealed by a connector until use. This combination of a moisturizing applicator that contains a moisturizing agent until use and an enclosure that is sealed by a connector until use provides additional assurance that the moisturizing agent will remain contained in the moisturizing device until use. A moisturizing agent that remains contained and sealed in a moisturizing device until needed for use is more desirable compared to a wetting agent that is only kept in a moisturizing applicator or only sealed until use, because there is less chance of wetting agent leaching into parts of the catheter system that should not be exposed to wetting agents, (eg handle, case, funnel).

The moisturizing device of the present application comprises a moisturizer applicator, wherein the moisturizer applicator is infused with a wetting agent.

The moisturizer applicator of the present invention is compressible. The moisturizer applicator can be soft. The moisturizer applicator can be fluffy or soft. The moisturizer applicator can be absorbent. The moisturizer applicator can be porous. The moisturizer applicator can be stringy. The moisturizer applicator releases a wetting agent when pressure is applied from within the chamber to the moisturizer applicator. The moisturizer applicator can deform under pressure. Without being part of the present invention, a moisturizer applicator may be pre-shaped after pressure is applied to the moisturizer applicator and subsequently removed. Without being part of the present invention, a moisturizer applicator may remain deformed after applying pressure to the moisturizer applicator. Without being part of the present invention, a moisturizer applicator may remain compressed after applying pressure to the moisturizer applicator.

Without being part of the present invention, the moisturizing devices described herein comprise a moisturizer applicator that is compressible and impregnable with a wetting agent. Without being part of the present invention, the wetting applicators described herein comprise a material that facilitates expansion of an opening therein over the wider diameters of a catheter tube, connector, or coupling element. Without being part of the present invention, the material facilitates expansion of the opening when the catheter tube is removed from a wrap or case [box]. Without being part of the present invention, the moisturizer applicator, or its opening, collapses or returns to its original shape, making contact with the outer surface of the catheter tube as the catheter is withdrawn. Without being part of the present invention, the humectant applicator, or its opening, retains its expanded shape, maintaining contact with the outer surface of the catheter tube when the catheter is withdrawn.

Without being part of the present invention, the moisturizing applicators described herein may comprise a flexible material such as a suitable foam. The foam can comprise a substance made of various compressible cell structures and air pockets that can absorb liquid. In some cases, the foam comprises polyethylene. In some cases, the foam comprises polyurethane. In some cases, the foam is a polyurethane foam. In some cases, the foam is a polyethylene foam. In some cases, the foam is an open cell, hydrophilic polyurethane foam. The foam can have a density of from about 1 pcf to about 10 pcf. The foam may have a density of approximately 5 pcf. The foam may not swell when exposed to water. Foam can swell between less than 1% and less than 10% when exposed to water. Foam can swell less than 2% when exposed to water. A foam that does not swell can be particularly useful because the dimensions of the foam remain constant regardless of the level of saturation of the foam. The foam may have an absorbency greater than 2 g water/g foam. The foam may have an absorbency greater than 8 g water/g foam. The foam may have an absorbency greater than 2 g water/g foam, but less than 20 g water/g foam. Such absorbency can ensure that the foam contains sufficient wetting agent. In some cases, the foam is a hydrophilic foam. A hydrophilic foam can allow the wetting agent to be easily absorbed into the foam during a filling process. Additional examples of wetting applicators are further described throughout this disclosure.

Without being part of the present invention, the moisturizing devices described herein contain a moisturizing applicator, wherein the moisturizing applicator is dry. Without being part of the present invention, the wetting devices described herein contain a wetting applicator, wherein the wetting applicator does not contain a wetting agent, but is capable of containing a wetting agent. Without being part of the present invention, the wetting device is configured to receive a wetting agent after the wetting applicator is contained within the enclosure/chamber of the wetting device. In the present invention, the wetting device comprises a port in the enclosure, through which an agent can be added. moisturizer to a moisturizing applicator present in a chamber of the moisturizing device. The port is located on a surface of the enclosure. See for example figures 6, 7, 13 and 14. The location of the port depends on the orientation of the assembly during the filling process. Without being part of the present invention, it may be advantageous to fill the wetting device when the assembly is in a vertical orientation, in which case a fill hole as shown in Figures 6 and 7 would be preferable. Otherwise, the assembly can be in a horizontal orientation during filling, which makes the filling hole position shown in Figures 13 and 14 more preferred.

Without being part of the present invention, wetting applicators may be sized to provide space between the wetting applicator and an interior surface of a wetting device enclosure. Moisturizing applicators may be sized to provide space between the moisturizing applicator and an interior surface of a chamber of the moisturizing device. For example, the total volume of the wetting applicator may be less than the total volume of the chamber. In these cases, the wetting applicator may be referred to as a "floating applicator." A dry float applicator can allow expansion of the wetting agent when a wetting agent is added during assembly. A floating wetting applicator can allow inadvertent movement of the wetting applicator within the chamber without a compressive force or pressure acting on the wetting applicator, which would otherwise inadvertently release the wetting agent and result in an uneven coating of the catheter tube. . This can occur if the catheter tube must be withdrawn at a slight angle (for example, prior to catheter use).

In the present invention, the wetting device comprises a wetting applicator, wherein the wetting applicator comprises at least one opening through which a catheter tube passes. Without being part of the present invention, the opening has a diameter that is less than the diameter of the catheter tube. Without being part of the present invention, the opening has a diameter that is the same diameter as the catheter tube. In some cases, the opening has a diameter greater than the diameter of the catheter tube. Without being part of the present invention, one end of the catheter tube is attached to a connector described herein, and the opening has a diameter that is less than the diameter of the connector. Without being part of the present invention, the opening has a diameter that is equal to the diameter of a connector. Without being part of the present invention, the opening has a diameter that is less than the diameter of a connector, so that the connector applies pressure on the wetting applicator as the connector passes through the wetting applicator. Without being part of the present invention, the opening has a diameter that is less than the diameter of a catheter tube, such that the catheter tube applies pressure on the wetting applicator as the catheter tube passes through the wetting applicator. .

The wetting device of the present invention comprises a wetting agent. Without being part of the present invention, wetting agents, as used herein, include liquids and gels. In some cases, the wetting agent is a liquid. In some cases, the liquid comprises water. In some cases, the liquid is water. Suitable wetting agents for use with the wetting devices described herein include, but are not limited to, deionized water, purified water, a light viscosity silicone fluid, and a mild saline solution. Wetting agents may also contain antimicrobials. Non-limiting examples of antimicrobials include chlorhexidine gluconate. Wetting agents may also contain a pain reliever. A non-limiting example of an analgesic is lidocaine. In some cases, the liquid is a solution. In some cases, the solution comprises a salt (eg, a saline solution). In some cases, the solution comprises a lubricant. Non-limiting examples of lubricants include a light viscosity silicone fluid or a lubricating gel. In some cases, the wetting agent is a gel. In some cases, the gel comprises carbomer. Non-limiting examples of gels include KY gel and other similar non-toxic lubricants. In some cases, in a male intermittent catheter embodiment, a minimum volume of 300 microliters of wetting agent is required, with 400 microliters of wetting agent being the preferred volume when water is applied to a catheter approximately 30 cm long, CH14 (4 0.33 mm diameter) with Feel Clean Technology lubrication [the term "Feel Clean" is used herein as a trademark].

Without being part of the present invention, the wetting devices described herein contain, or are capable of containing, one volume of wetting agent. The volume can be from about 100 microliters to about 1 milliliter. The volume can be from about 100 microliters to about 800 microliters. The volume can be from about 100 microliters to about 600 microliters. The volume can be from about 100 microliters to about 400 microliters. The volume can be from about 200 microliters to about 1 milliliter. The volume can be from about 200 microliters to about 800 microliters. The volume can be from about 200 microliters to about 600 microliters. The volume can be from about 200 microliters to about 400 microliters.

Without being part of the present invention, the wetting devices described herein are configured for use with a catheter tube, wherein the catheter tube is connected to a connector. By way of non-limiting example, the connector may be hollow and connect the catheter tube to a funnel to evacuate fluids from the catheter tube. Without being part of the present invention, the chamber of the wetting device is configured to allow passage of a connector, followed by the catheter tube. Without being part of the present invention, the connector passes through the wetting applicator as it passes through the chamber. Without being part of the present Invention, the connector applies pressure to the wetting applicator, thereby releasing the wetting agent from the wetting applicator to the catheter tubing. Without being part of the present invention, the connector applies pressure to the wetting applicator as it passes through the chamber, thereby releasing a wetting agent from the wetting applicator to the catheter tube as the catheter tube follows the connector through the chamber.

Without being part of the present invention, the wetting devices described herein are configured for use with a catheter tube, wherein the catheter tube is not connected to a connector. Without being part of the present invention, the catheter tube may be connected directly to a funnel, cuff, loop, additional tube, bag, etc. Without being part of the present invention, the catheter tube is passed through the wetting applicator as it passes through the chamber. In the present invention, a wetting agent is applied to the catheter tube as it passes through the wetting applicator. Without being part of the present invention, the catheter tube comprises a region with a larger diameter than the rest of the catheter tube, (eg, a bulge in the catheter tube). Due to its larger diameter, the region of the catheter tube can apply pressure to the wetting applicator, thereby releasing the wetting agent from the wetting applicator onto the catheter tube. In the present invention, movement of the catheter tube through the wetting applicator initiates the delivery of a wetting agent from a wetting applicator to the catheter tube.

In the present invention, the wetting devices described herein are configured for use with a catheter tube, wherein the catheter tube is not connected to a funnel. By way of non-limiting example, the funnels described in this document can comprise at least one material selected from thermoplastic polyurethane (TPU), thermoplastic elastomers (TPE) and polyvinyl chlorides (PVC).

The wetting device of the present invention may comprise a coupling or junction, also referred to herein as a coupling element. Couplings can create an interference fit with a chamber seal to achieve the desired seal. Sealing is required during storage and transport of the chamber to prevent leakage or evaporation of the wetting agent in case the chamber is pre-filled. The mating elements may be integral or arranged around the connector. Without being part of the present invention, the coupling elements are made of a different material than the connector.

The wetting device of the present invention comprises a chamber that is an enclosed space with at least two geometrically spaced openings in the chamber. Without being part of the present invention, a catheter tube is connected directly or indirectly to a connector, and the connector is extended through the chamber in a packaged state prior to use to seal the two in which the connector can be slid into the chamber so that in an operation state for use, the catheter tube can be drawn through the chamber. A wetting agent may be placed in the chamber to lubricate the catheter tube as it passes through the chamber.

In the present invention, the chamber is defined by a plurality of walls with a first end wall and a second end wall separated by a gap in the chamber. Without being part of the present invention, the first end wall and the second end wall each have a pre-formed opening provided through which the connector can encompass the chamber in a packaged state prior to use to seal the two openings and /or the connector is slidable into the chamber and/or the connector is slidable into the chamber so that in an operative state for use, the catheter tube can be passed through the chamber.

Without being part of the present invention, the chamber is defined by a plurality of walls with a first end wall opposite a second end wall along the axis of the catheter. At least one of the first and second end walls may each have an opening therethrough. The connector may encompass the chamber in a packaged state prior to use to seal the two openings. The connector can slide into the camera. The connector is slidable into the chamber so that in an operative state for use, the catheter tube can be passed through the chamber.

Without being part of the present invention, the present disclosure also provides a wetting device comprising: a chamber defined by a body having a hollow interior and two surfaces of the body partly separated by the hollow interior, each of the two surfaces of the body has an opening; and a moisturizing applicator that can be loaded with a wetting agent and having an opening, the moisturizing applicator arranged in the chamber with the opening between the two openings so that when a catheter tube passes through the chamber from a body surface to the another body surface, an outer surface of the catheter tube is properly wetted with the wetting device.

In yet another example not forming part of the present invention, the chamber is enclosed by a plurality of walls with a first end wall opposite a second end wall along the axis of the catheter. Each of the first and second end walls may have an opening therethrough that is axially aligned. Without being part of the present invention, the present disclosure further provides such a wetting device that can apply or activate a wetting agent at the time and point of insertion to minimize the amount of fluid required and avoid unwanted excessive amounts thereof. . The present disclosure further provides a system comprising the wetting device of the present invention and a catheter tube. See for example figures 1 and 2. In some cases, the catheter tube is connected to a funnel. In some cases, the catheter tube comprises a connector that connects the catheter tube to the funnel. In some cases, the connector is located within a chamber of the wetting device. The system, without being part of the present invention, comprises a case or wrapper that contains the wetting device and catheter tubing prior to use. See for example Figures 1 and 2. In some cases, the case or wrapper contains the wetting device and the catheter tube after use.

Without being part of the present invention, the present disclosure provides systems comprising the wetting devices and catheter tubing described herein. In the present invention, the wetting devices are configured for use with a catheter tube described herein. Without being part of the present invention, the catheter tubes may be straight, curved, or wrapped in wrappers and may be flexible to allow them to be bent without kinking. Without being part of the present invention, the catheter tubes described herein are made of a flexible material such as a thermoplastic elastomer. Thermoplastic elastomers are sometimes also called thermoplastic rubbers. Thermoplastic elastomers include, but are not limited to, a class of copolymers or a physical mixture of polymers (generally a plastic and a rubber) consisting of materials with both thermoplastic and elastomeric properties.

Thermoplastic elastomers can provide benefits common to both rubbery materials and plastic materials. The benefit of using thermoplastic elastomers is the ability to stretch to moderate elongations and return to their near original shape, creating longer life and better physical range than other materials. Alternative and additional materials for catheter tubes include polyvinyl chlorides and rubber. Other materials include those described in United States Patent Numbers 9,186,438 and 9,186,438 which generally describe polymer blends comprising a first and a second polymer, the first polymer being a thermoplastic or heat-curing polymer and the second polymer being a amphiphilic block copolymer possessing both hydrophilic and lipophilic properties. Polymer blends maintain a low kinetic coefficient of friction even when the surface is scratched, so lubricating properties are maintained across the entire surface of the article.

Without being part of the present invention, the catheter tubes described herein maintain a low friction property even when a surface thereof is scraped to maintain lubricating properties over the entire surface. For example, United States Patent No. 9,186,438 in the name of Gravesen et al., on "Medical Tube Article"["Tubular Medical Accessory"] describes an article that is a medical tube that comprises a mixture of polymers of a thermoplastic or thermosetting polymer base material and an amphiphilic block copolymer. Advantageously, without being part of the present invention, the catheter tubes described herein can be sufficiently wetted simply by cleaning an outer surface of the catheter tube with water or an aqueous solution. The hydrophilic part of the amphiphilic block copolymer can diffuse towards the surface, allowing a thinner lubricant layer to be used effectively.

Without being part of the present invention, the catheter tube comprises or is integrated with a polymer blend of a thermoplastic or thermosetting polymer base material and an amphiphilic block copolymer, for example as described in WO 2011/051439 filed on October 29, 2010. Without being part of the present invention, the catheter tube is coated with the polymer blend of a thermoplastic or thermosetting polymer base material and amphiphilic block copolymer, for example as the which is disclosed in document WO 2011/051439.

Without being part of the present invention, the present disclosure further provides a method for wetting a catheter tube, the method comprising passing a catheter tube through a wetting device described herein, thereby wetting the catheter tube with a wetting agent. In some cases, the wetting device has at least one opening. In some cases, the wetting device comprises at least a first and a second opening. Without being part of the present invention, the methods comprise passing the catheter tube through the wetting device by pulling on one end of a funnel attached to the catheter tube; and applying the wetting agent to a surface of the catheter tube when it is in the chamber.

Referring to the drawings and, in particular, to Figures 1, 2A and 2B, there is shown an intermittent catheter wrap generally represented by reference numeral 100.

The wrapper 100 may have a sleeve 102 comprising a top 103 and a bottom 105. The sleeve 102 may have a lid 104 that seals the sleeve. Within the package 100 is a catheter tube 110 as illustrated with a urinary catheter assembly in Figure 1. The catheter assembly may have a wetting device 120 for applying a wetting agent to the catheter tube 110 during removal of the catheter from the catheter. kit 102. Catheter tube 110 may have an insertion end 112 that can be inserted or forced into a patient's urethra. The catheter tube 110 may have an opposite discharge end 114. The discharge end 114 may be in fluid communication with a connector 160. The connector 160 may further be in fluid communication with a funnel 180 through which urine flows from the patient's bladder. The catheter assembly may have a handling region comprising, for example, a handle 178 and a sleeve 176 that at least partially covers the catheter tube 110 when the catheter assembly tube is removed from the case.

Generally, the catheter tube 110 is unlubricated in a packaged, prior to use, or unused state. In use, the catheter tube 110 is removed from the case 102 by pulling on the end of the funnel 180 as shown in Figure 2A. When the catheter tube is removed from the case 102, the wetting device 120 is activated and the catheter tube 110 is moistened by passing the catheter tube 110 through the wetting device 120. When the catheter tube is removed from the case 102 2B, the wetting device 120 remains in the case 102.

Figure 3 shows an isolated perspective of the wetting device 120 and funnel 180, together with the catheter tube 110 prior to use. As can be seen, catheter tubing 110 and connector 160 are threaded through wetting device 120, which includes rear 130 and front 128 wetting device covers. The funnel 180 and handle 178 can abut against the wetting device 120. Without being part of the present invention, connectors or other features connect or otherwise maintain a fluidic connection of the catheter tube 110 with the funnel 180, for example, through a connector 160. As shown above in Figure 2B and in use, wetting device 120 separates from catheter tube 110 when catheter tube 110 is withdrawn from case 102, with the moistening device 120 remaining in the case 102. Without being part of the present invention, the moistening device 120 is an integral part of the packaging. In other embodiments, the wetting device 120 is removable.

As shown in Figures 4 through 9, the wetting device 120 is configured such that removal of a catheter tube 110 from the package 100 engages the catheter and wetting device 120 to wet the catheter. Withdrawal of the catheter tube 110 may drag the catheter tube through the wetting device 120, resulting in the catheter tube becoming wet on an outer surface thereof. It should be noted that, as shown in Figure 2B, the wetting device 120 remains in the case after the catheter tube 110 is removed.

With respect to Figures 3, 4 and 5, the wetting device 120 can be retained in the wrap 100 even after the catheter tube 110 is removed from the wrap. Without being part of the present invention, the moisturizing device 120 is an integral part of the package. Without being part of the present invention, the wetting device 120 is removable.

The wetting device 120 may comprise a chamber 126. Preferably, the chamber 126 is in a closed structure except for at least two openings with a hollow interior. Chamber 126 can have any geometric shape or configuration, such as rectangular, square, circular, or oblong. In the present invention, the chamber 126 has a wall structure such that the at least two openings 136 and 142 are separated from each other by the hollow space.

In the present invention, the chamber 126 has a front section 122 and a rear section 124. The front section 122 and the rear section 124 are joined to form a chamber 126 between them. Preferably, the chamber 126 and its contents have been sterilized. The junction of the front section 122 and the rear section 124 may be at the facial surfaces 128 and 130, respectively, as shown. Preferably, a surface bond such as, for example, ultrasonic welding or a suitable adhesive is used to join the front section 122 and the rear section 124. In the example not forming part of the present invention, shown, the rear section 124 has a cavity 132 formed therein. The adjectives "forward" and "backwards" that describe sections 122 and 124, respectively, are not intended to imply a spatial or sequential relationship, but rather to guide the reader and facilitate understanding of the underlying principles. It should also be understood that the front section 122 and the rear section 124 may be a seamless structure.

Without being part of the present invention, the front section 122 may have an elongated portion 134 with an opening 136 through it. The rear section 124 may have an elongated portion 138 with an opening 142 through it. Therefore, openings 136 and 142 may be provided on opposite sides of chamber 126, and may be positioned in approximately axial or concentric alignment. Additionally, openings 136 and 142 may be substantially circular. Sections without the elongated portions are contemplated.

As shown, for example, in Figure 5, openings 136 and 142 may be large enough (eg, in diameter) to accommodate the outer dimension (eg, in diameter) of coupling elements 162 and 164 to establish a seal between them. Preferably, the seal is liquid tight. More preferably, the seal is fluid tight. As a person skilled in the art will appreciate, fluids are substances that are continuously deformed by a tangential force acting on a surface thereof. Fluids include gases, eg, air, and liquids, eg, water, aqueous mixtures, and gels.

Mating elements 162 and 164 may be integral with or arranged around connector 160. In some embodiments, mating elements 162 and 164 are formed of a different material than the connector. Other known methods of establishing the seal between the mating elements 162, 164 and the openings 136, 142 may also be suitable for use in accordance with the present disclosure.

Without being part of the present invention, it is shown that an internal surface of the opening 136 or the opening 142 has a plurality of ribs 140 (see also Figure 8). The plurality of ribs may be reinforcing ribs. Ribs 140 can increase the rigidity of openings 136 and 142 to resist deformation of openings 136 and 142 and maintain a seal with mating elements 162 and 164.

A compression bias can serve to seal the chamber 126 from the outside environment. The coupling element 162 is compression-pressed against an internal surface of the elongated portion 134. The coupling element 164 is compression-pressed against an internal surface of the elongated portion 138. The coupling element 162 is compression-pressed against a surface inner surface of elongated portion 134, and element 164 is compression-pressable against an inner surface of elongate portion 138. Without being part of the present invention, an inner surface of elongate portion 134 is compression-pressable against the coupling element 162 and an inner surface of the elongated portion 138 may be compression pressed against coupling element 164. Without being part of the present invention, the compression bias may be mutual, while in other examples not forming part of the invention, the compression bias can be a combination of the above. It will be appreciated that if at least one of the mating elements 162 and 164 is made of a different material than the connector, suitable sealing materials may be selected without regard to longitudinal strength or rigidity.

As shown in Figure 5, connector 160, in the packaged state, can be placed in openings 136 and 142.

Connector 160 may be a perforated cylindrical element. Connector 160 may span chamber 126 and openings 136 and 142 when placed in the catheter assembly. Connector 160 may have a first end 166 and a second end 168 with an intermediate section 172 between them. As mentioned, in the embodiment shown, connector 160 may have a mating element 162 proximal to the first end 166, and a mating element 164 proximal to the second end 168. Mating element 162 and mating element 164 they can simultaneously seal openings 136 and 142, respectively, when catheter tube 110 is unused or packaged. In such examples not forming part of the invention, when openings 136 and 142 are sealed, chamber 126 may be liquid-tight. In some embodiments, when openings 136 and 142 are sealed, chamber 126 can be fluid-tight to inhibit leakage into the wrapper 100.

The catheter tube 110 can be connected to the connector 160 at the first end 166 thereof. The funnel 180 can be connected to the second end 168 of the connector 160. In such a configuration, the connector 160 can provide liquid or fluid-tight communication between the catheter tube 110 and the funnel 180. In some cases, an inside diameter of the connector 160 is greater than or equal to an inner diameter of catheter tube 110. A larger inner diameter can prevent impingement of urinary discharge or flow. A larger bore can minimize pressure buildup.

As discussed above, the coupling elements 162 and 164 can be compressionally pressed against the elongated portions 134 and 138, respectively, to seal the chamber 126 from an outside environment. In some cases, this sealing aspect is important to allow the wetting device 120 to function. In some cases, this sealing aspect is important to allow the wetting device 120 to wet the catheter tube 110 upon removal from the package 100. In some cases, this sealing aspect is important to prevent the wetting agent from drying out. In some cases, this sealing aspect is important to prevent wetting agent from leaking out of chamber 126 and into package 100. Connector 160 is preferably made of a material that has a good moisture barrier for reasons appreciated by those skilled in the art. For example, a preferred material for connector 160 is HDPE because it has a low MVTR.

Referring to wetting device 120, a wetting applicator 150 may be disposed in chamber 126 around connector 160. Wetting applicator 150 may be a fluid-retaining element that allows fluid to be applied to catheter tubing 110 when catheter tubing is removed. catheter touches the item. The wetting applicator 150 may be made of a flexible or strong material that can absorb or retain liquid, lubricant, or the like (hereinafter collectively referred to as "lubricant"), and allow application of the lubricant upon contact with a tube to the wetting applicator. 150. A moisturizing applicator 150 is not - a limiting example of a flexible or resilient material is foam. Foam can be described as a substance made up of various compressible cellular structures and air pockets. The moisturizing applicator 150 can also be, among others, an absorbent pad, a sponge, a gel matrix, and a liquid capsule. The moisturizing device 120 may have a space 146 between the moisturizing applicator 150 and an internal surface of an enclosure of the moisturizing device 120, as exemplified in Figure 9.

The wetting applicator 150 may have an opening 152 therethrough (see also Figure 9) through which the connector 160 is disposed. The opening 152 may be sized to apply or transfer lubricant from the wetting applicator 150 to the catheter tube 110. It will be appreciated that opening 152 may be smaller in size than wetting device openings 136 and 142. In some cases, opening 152 is similar in size (eg, inside diameter to outside diameter) to the midsection. 172. In some cases, the outer diameter of the midsection 172 may be substantially similar to or slightly smaller in size than that of the catheter tube 110. In some cases, the outer diameter of the midsection 172 may be 0. 01 % to 10 % smaller than that of the catheter tube 110. In some cases, the outer diameter of the center section 172 can be 0.01% to 1% smaller than that of the catheter tube 110. This configuration can prevent the moisturizing applicator 150 from compressing before use. This configuration can also promote contact between substantially the entire length of the catheter tube 110 and the wetting applicator 150.

The opening 152 can be an opening, a slot, or a plurality of slits. Without being part of the present invention, the plurality of slots may form a cross section in the shape of an asterisk, star, or the like.

In some cases, a port 144 may be located on or within chamber 126, such as in front section 122, to introduce fluid, lubricant, or other suitable material into chamber 126. This fluid introduction may be used to charge the applicator. humectant 150 with a wetting agent. Although shown in Figures 5-7 on the front face of front section 122, port 144 can be positioned through or into other surfaces of moisturizing device 120 depending on the packaging for the moisturizing device, see for example, Figures 13 , 14 and 16. In some cases, port 144 comprises a one-way valve to only allow flow into chamber 126. In some cases, moisturizing applicator 150 is pre-filled with a wetting agent. In some cases, the wetting applicator is preloaded with a first wetting agent and is capable of receiving a second wetting agent or other agent through the port.

Once assembled, the aperture opening 152 can be aligned with apertures 136 and 142 so that an unwetted catheter tube 110 is first passed through aperture 136, and then withdrawn through aperture 152 where The wetting agent, absorbed or contained in the wetting applicator 150, is transferred to the outer surface of the catheter tube 110 to wet the outer surface along the length of the catheter tube. In this example, the catheter tube can now be adequately wetted and exits the wetting device 120 through opening 142, which can remove excess or unwanted wetting agent to make the catheter tube ready for use. In such an orientation, the discharge end 114 is wetted before the insertion end 112. Detail D shows how openings 136 and 142 create a seal against mating sections 162 and 164 of connector 160. The interference fit between these parts must be tight enough to prevent water leakage during the life of the device.

Referring to Figure 10, the catheter assembly 101 may comprise a wetting device 121, a wetting device applicator 151, and a connector 111. The catheter assembly may also comprise a handling region 181 comprising a handle, a funnel and an expandable sleeve. Region C provides additional detail of the coupling section of the wetting device 121 that seals against the coupling sections 163 and 165 when in a stored state.

Figure 11 and Figure 12 may represent an exterior view and a perspective view, respectively, of the catheter assembly shown in Figure 10, seen from the top of a case. This side of the catheter assembly may be referred to as the "top" of the catheter assembly and the top of their respective parts. The catheter assembly 101 may comprise a wetting device 121 and a connector 111. The catheter assembly may also comprise a manipulation region 181 comprising a handle, funnel, and expandable sleeve. Fill port or orifice 145 may be present on wetting device 121 to allow wetting agent to enter wetting device 121 and contact a wetting applicator (151 in Figure 10). As shown in Figure 11, the port may be present at the top of the wetting device, as opposed to one end (also known as a front section and rear section) of a wetting device as shown in Figure 7. Figure 11 shows an example not being part of the present invention that includes an accordion-foldable tablet or sleeve located over the handling region and funnel, which can be extended during removal of the catheter from the wetting device 121, which in turn time settles in the container or wrapper or case of the catheter 102 (see for example, 1 and 2, supra cited).

Figure 13 may represent an exploded view of the wetting device 121 of the catheter assembly 101 shown in any of Figures 10 to 12. The front section 123 may have the opening 137, the elongated portion 135, and the facial surface 129. rear section 125 may have opening 143, port 145, cavity 133, facial surface 131, and elongated portion 139. Connector 161 fits through opening 153 of moisturizing applicator 151. Connector 161 comprises the first end 167 and the second end 169, a central section 173 and coupling elements 163 and 165. The central section 173 can have a smaller circumference than the coupling elements, so that when assembled and before use, the central section 173 rests within opening 153 without applying any pressure to wetting applicator 151. As the catheter tube is deployed and pulled through opening 153, at least one of the coupling elements 163 and 165 passes through the opening 153, applying pressure to the wetting applicator 151, thus squeezing the wetting agent out of the wetting applicator and into the next tube of the catheter.

Figures 14 to 16 can show additional views of the wetting device 121 shown in Figure 13. Figure 14 shows a perspective view (not exploded) with elongated parts 141 and 139 in the front section 123 and the rear section 125, respectively. Figure 15 shows a cross section from a side view of the wetting device 121 in Figure 14, with the wetting applicator 151, the front section 123 having opening 137 and rear section 125 having opening 143. Figure 16 shows a cross-sectional end view of wetting device 121 with wetting applicator 151 having opening 153 and port 145. Feature 147 indicates a space between the moisturizing applicator 151 and an inner surface of an enclosure of the moisturizing device 121, as described herein.

Referring to Figures 17-20, catheter tube 210 may have an insertion end 212 that can be inserted into a patient's urethra and a discharge end 214 in fluid communication with a connector 260 and funnel 280 through from which urine flows from the patient's bladder. The catheter tube 210 may be dry or unlubricated in a packed state. Removal of catheter tube 210 from wrapper 200 can activate wetting device 220. As catheter tube 210 passes through wetting device 220, a wetting agent can be applied to the exterior surface of the catheter tube. As with the first embodiment, the wetting device 220 may be in the wrap 200 and may be retained in the wrap when the catheter tube 210 is removed. Alternatively, the wetting device 220 may be an integral part of the wrap 200. The wetting device 220 may have a front section 222 and a rear section 224 that together form a chamber 226 between them. In the exemplary embodiment shown, the front section 222 has a projecting element 234 with an opening 236 through it. The rear section 224 may have a projecting element 238 with an opening 242 through it. These outwardly protruding elements 234, 238 can create additional volume in chamber 226 and as such the depths are sized accordingly. In addition, there may be two aligned openings 236, 242, preferably axially aligned, disposed at opposite ends of chamber 226. The catheter assembly shown is stored within case body 202 and can be removed through an opening (not shown) under cover 204.

As exemplified in Figures 18-22, the wetting devices described herein may be configured for use with a catheter tube, wherein the catheter tube is attached or connected to a connector. By way of non-limiting example, the connector may connect the catheter tube to a funnel. In some cases, the connector 260 extends through the chamber 226. In some cases, the connector plugs at least one of the openings 236 and 242 in a packaged or unused state. Like connector 160, connector 260 may have an intermediate section 272 between a first end 266 and a second end 268. Connector 260 may have a mating element 262 near the first end 266 and a mating element 264 near the second end 268. The coupling element 262 and the coupling element 264 can simultaneously seal the openings 236 and 242, respectively. Displacement of connector 260 opens openings 236 and 242.

In some cases, the catheter tube 210 is connected to the first end 266 of the connector 260. See, for example, Figure 18. In some examples not being part of the present invention, the catheter tube 210 is placed in a bore 274, where it is press fit or ultrasonically welded. Funnel 280 can be connected to and fit around a second end 268 of connector 260. Again, a press fit or sonic welding can be used. Such a configuration, namely where catheter tube 210 fits into connector 260 and connector 260 fits into funnel 280, can ensure that there is no pressure buildup due to cross-sectional flow constriction.

Moisturizing applicator 250, like moisturizing applicator 150, may have an opening 252 through it. Moisturizing applicator 250 may be arranged in chamber 226 with connector 260 disposed in opening 252. In some cases, moisturizing applicator 250 is compressible. In some cases, the moisturizing applicator 250 is impervious to liquids. In some cases, the wetting applicator 250 is sized to apply liquid to the catheter tube 210. In some cases, the wetting applicator 250 is sized, in the dry state, so that there is a space 246 between the outer circumference of the wetting applicator and a internal diameter of chamber 226 to allow the wetting applicator to move and to provide space for expansion of the wetting applicator.

As shown, a port 244 may be located through the top wall in the rear section 224. Port 244 is for filling chamber 226 with lubricant to charge wetting applicator 250. It will be appreciated that port 244 may be provided into or through other surfaces of the wetting device 220 depending on the packaging for the wetting device. Port 244 can be a one-way port to prevent leaks.

In an assembled state, openings 236 and 242 may be in concentric alignment with connector 260 and opening 252. In other embodiments, openings 236 and 242 are not in concentric alignment with connector 260 and opening 252. In use, connector 260 may be displaced, thus breaking the seal at openings 236 and 242. A dry catheter tube 210 can first be passed through opening 236 into chamber 226. Catheter tube 210 can then be passed through opening 252 where a wetting agent is applied in wetting applicator 250 to an exterior, such as the exterior or outer surface, of catheter tube 210. Catheter tube 210, now lubricated, can be withdrawn from chamber 226 through through opening 242 (which removes excess lubricant) and is ready for use by a patient.

Referring to Figures 23-25, a third non-inventive example of a moisturizing device 320 of the present disclosure is shown. In this example, the moisturizing device 320 is arranged in a package 300.

The wrapper 300 has a body 302 and a removable cap 304. The body 302 has a proximal end 306 and a distal end 308 that is opposite the proximal end. Cap 304 is connected to and preferably attached to a proximal end 306.

Wrap 300 differs from wraps 100 and 200 in that catheter tube 210 is not removable therefrom. Rather, the catheter tube 210 is integral with the wrapper. In addition, catheter tube 210 is in fluid communication with a discharge opening 380 at distal end 308. Body 302 has a drive mechanism, such as a plunger (not shown), to push catheter tube 210 through the catheter. wetting device 320. At the same time, or in a sequence, the drive mechanism can open the discharge port 380. Consequently, unlike wetting devices 120 and 220, wetting device 320 lubricates the catheter tubing. 210 from the insertion end 212 to the discharge end 214.

As shown in Figure 24, the moisturizing device 320 may have a front section 322 and a rear section 324. A chamber 326 may be formed between the front section 322 and the rear section 324. The chamber 326 may contain an applicator. humectant 350 having an opening 352 through it. As shown, moisturizing applicator 350 can be cylindrical and generally conforms to the shape of body 302. It should be noted that moisturizing applicator 350 will preferably conform to the shape of body 302 so that if body 302 has a different, like the 350 oblong moisturizing applicator will fit that shape. The chamber 326 may have an opening 336 through the forward section 322 and an opening 342 through the rear section 324. These openings 336, 342 may be arranged in concentric alignment with the catheter tube 210 so that the catheter can be push through chamber 326 along its central axis.

Figure 24 shows a side view of a cross section of a wrapper 300. On the left, the wrapper 300 is shown with the cap 304 (not shown) removed to expose the locator tip 334. The locator tip 334 can be described as conical. , with a slope that can gradually increase to the base of the locator tip. The locator tip 334 can be described as having a cone shape. Although hollow, the locator tip 334 can be described as having a flat end. Locator tip 334 can be described as having a blunt end. The end of the locator tip has a diameter that is smaller than the base of the locator tip where it meets the housing of the device. A cross-sectional side view shows the catheter tube 210 protected from exposure by the locator tip 334. Also, in this exemplary case, the catheter tube 210 must be pushed through a wetting device 320 and the locator tip 334 before from coming into contact with tissue. The locator tip 334 may have a tapered region near the locator tip opening 368. Fig. 24 further shows the housing lip 372, 374 and a locator tip ring 370, 376 that attaches the locator tip to the body.

The chamber 326 can be sealed in a packaged or pre-use state by a coupling element 362 in the front section 322 and by a coupling element 364 in the rear section 324. The coupling elements 362 and 364 may be made of a material pierceable with the catheter tube 210. Such materials are, but are not limited to, a metal sheet and a plastic sheet such as polyethylene (PE) or polypropylene (PP) or a coated paper. The coupling elements 362 and 364 may have features such as perforations, notches, weakened areas, and the like that facilitate drilling. The coupling elements 362 and 364 are preferably the same size and shape.

Alternatively, it is envisioned that a chamber, such as chamber reference number 226, may be used, and openings 236 and 242 are sealed by a coupling element incorporated into the interior of lid 304.

Tail section 324 may also have an extension, namely extension 338. Extension 338 is a cylindrical protrusion having a tapered opening that tapers toward chamber 326. Advantageously, extension 338 facilitates pushing catheter tube 210 out of the packaging by channeling the catheter tube 210 toward a central axis of the openings 336 and 342.

As shown in Figure 25, catheter tube 210 has been pushed through chamber 326 and proximal end 306 and is therefore now lubricated and in use. The urethra into which the catheter tube 210 has been inserted is not shown. As the catheter tube 210 is pushed through the chamber 326, the drive mechanism also creates a discharge opening 380 at the distal end 308. The catheter tube 210 is in fluid communication with discharge port 380.

In an alternative example not forming part of the invention, body 302 may be made of a soft, flexible material capable of accordion-folding like a bellows to push catheter tube 210 through wetting device 320.

Referring to Figure 26, a fourth non-inventive example of a wetting device 420 in accordance with the present disclosure is shown. The wetting device 420 is arranged in the wrapper 400.

The wrap 400 has a locator tip 490 and a body 402 in which a wetting device chamber 426 can be retained and a cap 404 that can be placed on a proximal end 406 of the wrap to close the wrap. A fitting 460 for sealing wetting device 420 is attached to or integral with cap 404. Unlike the first, second and third examples discussed above, catheter tube 210 may not be attached to a connector or fitting. In this fourth example, the catheter tube 210 can be coupled to an actuator (not shown) that pushes the catheter tube linearly in one direction from the distal end 408 to the proximal end 406 and through the wetting device 420. The catheter tube 210 is dry or unmoistened before being pushed through the moistening device 420, as in a packed state.

The chamber 426 of the wetting device 420 can be fabricated between a front section 422 and a rear section 424. Two aligned openings 436, 442, in some cases axially aligned, are disposed at opposite ends of the chamber 426, such as opening 436 a through front section 422 and opening 442 through rear section 424. In preferred examples not forming part of the invention, front section 422 has an elongated portion 434 through which opening 436 can be arranged The rear section may have an elongated portion 438 through which the opening 442 is provided.

The elongated portions 434, 438 may be cone-shaped extensions of the front and rear sections 422 and 424, respectively. Elongated portion 434 may extend away from chamber 426, while elongated portion 438 extends into chamber 426. The inside diameter of each of elongated portions 434, 438 may taper in one direction from distal end 408 to the proximal end 406. The rear section 424 may also form a tubular covering around the catheter tube 210 in a direction away from the chamber 426. Such a configuration may serve to protect an outer surface of the catheter tube 210 from contamination. This configuration can further facilitate movement of catheter tube 210. For example, this configuration can guide or assist catheter tube through opening 442 into chamber 426 and then through opening 436 out of chamber 426. .

As discussed above, the coupling 460 can be attached or attached directly to the lid 404 and seal the chamber 426. Thus, by removing the lid 404, the coupling 460 can also be removed from the chamber 426, thus creating a volume to allow the catheter tube 210 to be pushed through.

The coupling 460 may have a coupling element 462 proximate the first end 466, and a coupling element 464 proximate the second end 468, with a center 472. The coupling element 462, 464 can simultaneously seal the chamber 426, preferably at the openings 436 and 442, respectively. The coupling 460 may be made of a material that has a moisture barrier such as HDPE or PP.

A wetting applicator 450, similar to wetting applicator 150, 250, 350, can be arranged in chamber 426 and can function in substantially the same way. The wetting agent 450 may have an opening 452 through which the catheter tube 210 passes, and preferably comes into contact, when wetted by the wetting applicator.

Referring to Figures 27 to 33, the wetting devices described herein may be useful in catheter assemblies for insertion of a catheter tube into the female urethra. While Figures 27 through 33 are illustrative of wetting devices in such catheter assemblies, it is understood that some features and configurations depicted in these figures would also be suitable for catheter assemblies intended for insertion of a catheter tube into a male urethra.

Figure 27 shows a female catheter assembly 500, comprising housing 502 and cap 506. The wetting device and wetting applicator (not shown) are contained within housing 502. It should be noted that the wetting device contained within is adequately sized for such a compact catheter assembly.

Figure 28 depicts a cross-sectional side view of a wetting device and catheter assembly at the distal end of the catheter tube, which would be the end for urethral insertion. This side view cross section may be a view of the internal contents of catheter assembly 500 as shown in Figure 27. Catheter tube 510 may pass through humectant applicator 550 which is contained in chamber 532, enclosed by enclosure 530. Feature 544 is an optional fill port for adding a wetting agent to wetting applicator 550. Feature 572 is the proximal portion of a tapered connecting tube placed through wetting chamber 532.

Figure 29 shows a top view of a catheter assembly, before connector 560 has passed through portion 558 upon removal of the catheter assembly from its case. Funnel connection 580 (not shown) to connector 560 sits within locator tip 567, which is part of a locator comprising locator tip 567, locator tip base 568, and locator handle. locator 558. Connector 560 sits within and seals against the wetting device (not shown) during storage. Connector 560 is pulled and the wetting device, which is attached to the case, is activated to release the wetting agent upon removal of the catheter assembly from the case.

Figure 30 shows an exploded view of the wetting device 520. The wetting device 520 may be particularly suitable for a female catheter assembly that is long and cylindrical, such as the catheter assembly depicted in Figure 10, but can also be used for a female catheter assembly that is long and cylindrical. male catheter. The wetting device 520 has a front section 522 comprising the opening 536, the elongated part 534 and the surface 528 with the port 544. The connector 560 has a first end 566, a second end 568, coupling elements 562 and 564 and a center section 572. Center section 572 can have a smaller circumference than coupling elements 562 and 564, so that when assembled and prior to use, center section 572 rests within opening 552 without applying any pressure to the applicator of humectant 550. As the catheter tube is deployed and pulled through opening 552, at least one of coupling elements 562 and 564 pass through opening 552, applying pressure to humectant applicator 550, squeezing thus the wetting agent out of the wetting applicator and into the next catheter tube. Moisturizing device 520 may comprise rear section 524 connecting to front section 522 to contain moisturizing applicator 550. Feature 582 is the interior of the rear cover of moisturizing device 520; 556 is the rear cover for the 532 humidification chamber.

Figure 31 shows a cross-sectional side view of moisturizing device 520. Moisturizing device 520 comprises openings 536 and 542, moisturizing applicator 550, moisturizing applicator opening 552, front section 522, and rear section 524. , as well as the port 544 to introduce the wetting agent in the wetting applicator 550.

Figure 32 shows a cross section of a side view of a catheter assembly including a wetting device 520 with a wetting applicator 550, a funnel 580, a manipulation feature (outer shell or sleeve) 502, and a catheter tube. 510. The circled region shows the junction between the characteristic manipulation 502 and the neck. This junction may be hermetic to ensure a sterile seal. The joint can be formed by laser welding. The joint can be formed by ultrasonic welding or any other continuous welding technique.

Figure 33 shows an exemplary female catheter assembly in a stored state (top) and an activated state (bottom). The catheter assembly comprises a wetting device described herein between the funnel 580 and the catheter tube 510. In the stored state, the catheter tube is not covered by the sleeve 512. In an activated state, the sleeve 512 is pulls over catheter tube 510, through locator tip 584. As the catheter is withdrawn from the container, the wetting device is activated, wetting the catheter tube as the tube passes through the wetting device and out of the container. The sleeve assembly, including the handle and locator tip, are pulled [or pushed] onto the catheter simultaneously or substantially simultaneously as the catheter is lubricated or wetted with the wetting device solution. After use, the catheter tube is reinserted into the container, pushing the sleeve assembly down into its storage position.

It should be noted that the terms "first", "second", "third", "forward", "back", "upper", "lower", "higher" and "lower" and the like have been used herein to modify various elements. However, these modifiers do not imply a spatial, sequential, or hierarchical order for the modified elements unless specifically stated.

While the present disclosure has been described with reference to one or more embodiments, it will be understood by those skilled in the art that various changes may be made without departing from the scope of the present disclosure. In addition, many modifications can be made to adapt a particular situation or material to the knowledge of the present disclosure without departing from the scope thereof.

Claims (14)

1. Wetting device (120, 220, 520) for a catheter tube (110, 210, 510) comprising: a) an enclosure enclosing a chamber (126, 226, 532) having at least two openings (136, 142, 236, 242, 536) through which the tube (110,210,510) can pass through; b) a humectant applicator (150, 250, 550) located in the chamber (126, 226, 532) which has an opening (152, 252, 552) through which the tube (110, 210, 520) can cross; characterized in that the moisturizer applicator (150, 250, 550) is configured to release a wetting agent when pressure is applied from within the chamber (126, 226, 532) to the moisturizer applicator (150, 250, 550), wherein the enclosure comprises a port (145, 244, 544) for adding the wetting agent to the wetting applicator (150, 250, 550). The wetting device of claim 1, wherein the catheter is a urinary catheter. The wetting device of claim 2, wherein the urinary catheter is suitable for insertion into a male urethra or a female urethra. The moisturizing device of claim 1, wherein the moisturizer applicator (150, 250, 550) is compressible and the moisturizer applicator (150, 250, 550) is infused with the wetting agent. A system comprising a wetting device (220, 520) of any one of the preceding claims and a catheter tube (210, 510) comprising a connector (260, 560) connecting the catheter tube (210, 510) to a funnel (280, 580). The system of claim 5, wherein the connector (260, 560) is positioned within the wetting device (220, 520). The system of claim 6 wherein the connector (260, 560) has a first plug (262, 562) at a first end and a second plug (264, 564) at a second end, where the first plug (262, 562) 562) and the second plug (264, 564) seal the wetting device (220, 520) until the connector (260, 560) passes through the wetting device (220, 520). The system of claim 7, wherein at least one region of the connector (260, 560) comprises a diameter that is greater than the diameter of the opening (252, 552) of the moisturizer applicator. The system of claim 8, wherein the connector (260, 560) applies pressure to the wetting applicator (250, 550) to release the wetting agent as the catheter tube is moved through the wetting device ( 220, 520). The system of claim 5, further comprising a manipulation sleeve (502), wherein the manipulation sleeve (502) extends over the catheter tube (510) when the catheter tube (510) is withdrawn. of the enclosure. The system of claim 5, comprising the wetting agent. A method of using the system of any one of claims 5 to 11, comprising removing the catheter tube (210, 510) from a wrapper and moistening the catheter tube (210, 510), wherein the removal and wetting occur substantially simultaneously. The method of claim 12, wherein removing the catheter tube from a wrap (200) moistens the catheter tube (210). The method of claim 13, wherein the manipulation sleeve (502) extends substantially simultaneously over the catheter tube (510) as the wetting agent is delivered into the catheter tube (510).